David Freeman: Debarment Order, 26784-26785 [2013-10973]
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26784
Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: May 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–10887 Filed 5–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0865]
David Freeman: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
David Freeman for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Freeman
was convicted of introducing and
delivering for introduction into
interstate commerce of a misbranded
drug, which relates to the development
or approval, including the process for
development or approval, of drug
products and to the regulation of drug
products under the FD&C Act. In
addition, FDA determined that the type
of conduct that served as the basis for
Mr. Freeman’s conviction undermines
the process for the regulation of drugs.
Mr. Freeman was given notice of the
proposed debarment and an opportunity
to request a hearing within the
prescribed timeframe by regulation, but
failed to respond. Mr. Freeman’s failure
to respond constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is effective May 8,
2013.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
VerDate Mar<15>2010
17:56 May 07, 2013
Jkt 229001
finds that the individual has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of drug products under
the FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On May 5, 2010, Mr. Freeman pleaded
guilty to a misdemeanor offense of
introducing and delivering for
introduction into interstate commerce of
a misbranded drug in violation of 21
U.S.C. 352(o), 331(a), and 333(a)(1). On
July 7, 2011, the U.S. District Court for
the District of Nevada entered judgment
against Mr. Freeman for the
misdemeanor offense of misbranding.
The FDA’s finding that debarment is
appropriate is based on the
misdemeanor conviction referenced
herein. The factual basis for the
conviction is as follows: On July 23,
2008, Agents from Customs and Border
Protection found two express mail
packages at JFK International Mail
Facility, each with a return address of
Muhi Trading Corporation, Bahadur
Manzil. A border search was conducted
on both packages, which revealed 1,000
capsules labeled as the prescription
drug omeprazole in each package. The
pills were in blister packs on which was
written ‘‘Omega Biotech LTD.’’ Mr.
Freeman and his co-defendant, Mr.
Ashley Brandon Foyle, were the
importers of record for the packages. At
all relevant times, neither Muhi Trading
Corporation nor Omega Biotech LTD.
were registered to manufacture, prepare,
propagate, compound, or process drugs.
On January 20, 2009, an Agent with
the Office of Criminal Investigations at
FDA (OCI) conducted an undercover
purchase of omeprazole through a Web
site Mr. Freeman and Mr. Foyle used to
sell their misbranded drugs. Mr.
Freeman and Mr. Foyle repackaged
omeprazole in their apartment and
mailed it to the undercover agent.
Laboratory testing of the tablets
confirmed that the tablets contained
omeprazole. On February 24, 2009, OCI
agents searched Mr. Freeman and Mr.
Foyle’s residence and found
unapproved drugs. The omeprazole pills
that Mr. Freeman and Mr. Foyle
imported, repackaged and sold had not
been approved by or registered with
FDA. At no time was Mr. Freeman and
Mr. Foyle’s apartment registered as a
location where drugs could be
manufactured, prepared, propagated,
compounded, or processed.
As a result of his convictions, on
October 31, 2012, FDA sent Mr.
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Frm 00038
Fmt 4703
Sfmt 4703
Freeman a notice by certified mail
proposing to debar him for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. The proposal
was based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act that
Mr. Freeman was convicted of a
misdemeanor under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of drug
products and to the regulation of drug
products under the FD&C Act, and the
conduct that served as the basis for Mr.
Freeman’s conviction undermines the
process for the regulation of drugs
because the introduction of misbranded
drugs into interstate commerce is
prohibited by the FD&C Act. The
proposal also offered Mr. Freeman an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Freeman failed to respond within the
timeframe prescribed by regulation and
has, therefore, waived his opportunity
for a hearing and waived any
contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act under authority delegated to him
(Staff Manual Guide 1410.35), finds that
David Freeman has been convicted of a
misdemeanor under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of drug
products and relating to the regulation
of drug products under the FD&C Act,
and that the type of conduct that served
as the basis for the conviction
undermines the process for the
regulation of drugs.
As a result of the foregoing finding,
Mr. Freeman is debarred for 5 years
from providing services in any capacity
to a person with an approved or
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES), (see sections 306(c)(1)(B),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 355a(c)(1)(B),
(c)(2)(A)(iii), and 321(dd))). Any person
with an approved or pending drug
product application who knowingly
employs or retains as a consultant or
E:\FR\FM\08MYN1.SGM
08MYN1
Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Notices
contractor, or otherwise uses the
services of Mr. Freeman, in any capacity
during Mr. Freeman’s debarment, will
be subject to civil money penalties
(section 307(a)(6) of the FD&C Act (21
U.S.C. 355b(a)(b)). If Mr. Freeman
provides services in any capacity to a
person with an approved or pending
drug product application during his
period of debarment he will be subject
to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Mr. Freeman during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Freeman for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2012–
N–0865 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for
Regulatory Affairs, Office of Regulatory
Affairs.
[FR Doc. 2013–10973 Filed 5–7–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0722]
Guidance for Industry: Implementation
of an Acceptable Abbreviated Donor
History Questionnaire and
Accompanying Materials for Use in
Screening Frequent Donors of Blood
and Blood Components; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Implementation
of an Acceptable Abbreviated Donor
History Questionnaire and
Accompanying Materials for Use in
Screening Frequent Donors of Blood and
Blood Components’’ dated May 2013.
The guidance document recognizes the
abbreviated donor history questionnaire
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:56 May 07, 2013
Jkt 229001
26785
and accompanying materials (aDHQ
documents), version 1.3 dated December
2012, prepared by the AABB Donor
History Task Force, as an acceptable
mechanism for collecting blood donor
history information from frequent
donors of blood and blood components
that is consistent with FDA’s
requirements and recommendations for
collecting donor history information.
The aDHQ documents will provide
blood establishments that collect blood
and blood components with a specific
process for administering questions to
frequent donors of blood and blood
components to determine their
eligibility to donate. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
October 2011.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
blood donor history information from
frequent donors of blood and blood
components that is consistent with
FDA’s requirements and
recommendations. The aDHQ User
Brochure defines a frequent donor as a
donor who has previously donated two
times using the full-length donor history
questionnaire, one donation of which
occurred within the previous 6 months.
The aDHQ documents will provide
blood establishments that collect blood
and blood components with a specific
process for administering questions to
frequent donors of blood and blood
components to determine their
eligibility to donate. The guidance also
advises licensed manufacturers who
choose to implement the acceptable
aDHQ documents on how to report the
manufacturing change consisting of the
implementation of the aDHQ documents
under 21 CFR 601.12.
In the Federal Register of October 24,
2011 (76 FR 65735), FDA announced the
availability of the draft guidance of the
same title dated October 2011. FDA
received some comments on the draft
guidance and those comments were
considered as the guidance was
finalized. A summary of changes
includes: Referencing the most current
version of the acceptable aDHQ
documents, clarifying that the fulllength and abbreviated questionnaires
are designed to be implemented
together, and editorial changes to
improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated October 2011.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Implementation of an
Acceptable Abbreviated Donor History
Questionnaire and Accompanying
Materials for Use in Screening Frequent
Donors of Blood and Blood
Components’’ dated May 2013. The
guidance document recognizes the
aDHQ documents, version 1.3 dated
December 2012, prepared by the AABB
Donor History Task Force, as an
acceptable mechanism for collecting
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 601.12 and Form FDA 356(h)
have been approved under OMB control
number 0910–0338; and the collections
of information in 21 CFR 640.63 have
been approved under OMB control
number 0910–0116.
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Frm 00039
Fmt 4703
Sfmt 4703
II. Paperwork Reduction Act of 1995
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26784-26785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0865]
David Freeman: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
David Freeman for 5 years from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Mr. Freeman was convicted of
introducing and delivering for introduction into interstate commerce of
a misbranded drug, which relates to the development or approval,
including the process for development or approval, of drug products and
to the regulation of drug products under the FD&C Act. In addition, FDA
determined that the type of conduct that served as the basis for Mr.
Freeman's conviction undermines the process for the regulation of
drugs. Mr. Freeman was given notice of the proposed debarment and an
opportunity to request a hearing within the prescribed timeframe by
regulation, but failed to respond. Mr. Freeman's failure to respond
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is effective May 8, 2013.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of drug products under the FD&C Act, and if
FDA finds that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
On May 5, 2010, Mr. Freeman pleaded guilty to a misdemeanor offense
of introducing and delivering for introduction into interstate commerce
of a misbranded drug in violation of 21 U.S.C. 352(o), 331(a), and
333(a)(1). On July 7, 2011, the U.S. District Court for the District of
Nevada entered judgment against Mr. Freeman for the misdemeanor offense
of misbranding.
The FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: On July 23, 2008, Agents from Customs and
Border Protection found two express mail packages at JFK International
Mail Facility, each with a return address of Muhi Trading Corporation,
Bahadur Manzil. A border search was conducted on both packages, which
revealed 1,000 capsules labeled as the prescription drug omeprazole in
each package. The pills were in blister packs on which was written
``Omega Biotech LTD.'' Mr. Freeman and his co-defendant, Mr. Ashley
Brandon Foyle, were the importers of record for the packages. At all
relevant times, neither Muhi Trading Corporation nor Omega Biotech LTD.
were registered to manufacture, prepare, propagate, compound, or
process drugs.
On January 20, 2009, an Agent with the Office of Criminal
Investigations at FDA (OCI) conducted an undercover purchase of
omeprazole through a Web site Mr. Freeman and Mr. Foyle used to sell
their misbranded drugs. Mr. Freeman and Mr. Foyle repackaged omeprazole
in their apartment and mailed it to the undercover agent. Laboratory
testing of the tablets confirmed that the tablets contained omeprazole.
On February 24, 2009, OCI agents searched Mr. Freeman and Mr. Foyle's
residence and found unapproved drugs. The omeprazole pills that Mr.
Freeman and Mr. Foyle imported, repackaged and sold had not been
approved by or registered with FDA. At no time was Mr. Freeman and Mr.
Foyle's apartment registered as a location where drugs could be
manufactured, prepared, propagated, compounded, or processed.
As a result of his convictions, on October 31, 2012, FDA sent Mr.
Freeman a notice by certified mail proposing to debar him for 5 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act that Mr.
Freeman was convicted of a misdemeanor under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of drug products and to the regulation of drug
products under the FD&C Act, and the conduct that served as the basis
for Mr. Freeman's conviction undermines the process for the regulation
of drugs because the introduction of misbranded drugs into interstate
commerce is prohibited by the FD&C Act. The proposal also offered Mr.
Freeman an opportunity to request a hearing, providing him 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. Mr. Freeman failed to respond within the timeframe prescribed
by regulation and has, therefore, waived his opportunity for a hearing
and waived any contentions concerning his debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(i)(I) of the FD&C Act under authority delegated to him
(Staff Manual Guide 1410.35), finds that David Freeman has been
convicted of a misdemeanor under Federal law for conduct relating to
the development or approval, including the process for development or
approval, of drug products and relating to the regulation of drug
products under the FD&C Act, and that the type of conduct that served
as the basis for the conviction undermines the process for the
regulation of drugs.
As a result of the foregoing finding, Mr. Freeman is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 355a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or
[[Page 26785]]
contractor, or otherwise uses the services of Mr. Freeman, in any
capacity during Mr. Freeman's debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 355b(a)(b)). If
Mr. Freeman provides services in any capacity to a person with an
approved or pending drug product application during his period of
debarment he will be subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Mr. Freeman during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Mr. Freeman for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0865 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-10973 Filed 5-7-13; 8:45 am]
BILLING CODE 4160-01-P
